Effect of Maternal Supplementation From Preconception to Lactation on Child Growth and Development

NCT06641349 | Completed

• 1 other identifier: 46670
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the long-term effects of maternal multiple micronutrient supplementation from preconception through to lactation on child neurodevelopment and growth in a resource-limited setting where there is a high burden of malnutrition. The main questions it aims to answer are:

• Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child neurodevelopment?
• Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child growth? This is a cross-sectional follow up study to a substudy of breastmilk composition and infant growth within the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial, wherein mothers were randomized to receive a multiple micronutrient supplement from preconception through to lactation or the standard of care (ClinicalTrials.gov Identifier: NCT04451395).

Conditions

Malnutrition; Growth &Amp; Development

Keywords

malnutrition; multiple micronutrient supplement; neurodevelopment; growth

Outcome Measures

Primary Outcomes (1)

• Full scale IQ score

  Wechsler Preschool and Primary Scale of Intelligence (WPPSI), minimum score: 40 and maximum score: 160 (higher scores mean a better outcome)

  At 4 years of age

Secondary Outcomes (3)

• Fine and gross motor skills score

  At 4 years of age

• Height

  At 4 years of age

• Head circumference

  At 4 years of age

Other Outcomes (2)

• Weight

  At 4 years of age

• Middle upper arm circumference

  At 4 years of age

Study Arms (2)

Children born to mothers who received a multiple micronutrient supplement

From preconception to 6-months postpartum, mothers received a multiple micronutrient supplement (oral tablet at UNIMMAP composition \[30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine\])

Children born to mothers who received the standard of care

From preconception to 6-months postpartum, mothers received the standard of care

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residence within Matiari District, Pakistan

You may qualify if:

• Child participated in the MaPPS Trial Breastmilk Sub-study at 3-months of age
• Child has reached their fourth birthday
• Child is available in the study catchment area (Matiari District)

Sponsors & Collaborators

• University of Toronto: lead
• Aga Khan University: collaborator

Study Sites (1)

Aga Khan University

Matiari, Pakistan

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Nutritional Sciences

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: January 13, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

PA (1)